[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advancedmetastatic-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advancedmetastatic-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100547937","phase-1-study-of-ism3412-in-participants-with-locally-advancedmetastatic-solid-tumors-100547937",false,"NCT06414460","Study of ISM3412 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","A Phase 1\u002F2, Open-Label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics\u002FPharmacodynamics, and Preliminary Efficacy of ISM3412 in Participants With Locally Advanced\u002FMetastatic Solid Tumors","Inclusion Criteria:\n\n1. Male or female participants with age ≥18 years at the time of signing the informed consent.\n2. Histologically confirmed unresectable locally advanced or metastatic solid tumors with confirmed homozygous MTAP deletion, who have disease progression after standard therapy, intolerable to standard therapy, or for whom no standard therapy exists.\n3. Have measurable or evaluable lesions in Part 1 and at least one measurable target lesion in Part 2 as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.\n4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) ≤1.\n5. Life expectancy of ≥12 weeks as judged by the investigator.\n6. Adequate organ function as determined by medical assessment.\n7. Capable of providing signed ICF and complying with the requirements and restrictions listed in the ICF and in this study protocol.\n\nExclusion Criteria:\n\n1. Prior treated with other MAT2A inhibitors and\u002For PRMT inhibitors.\n2. Participation in other therapeutic clinical studies within 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment.\n3. Anti-tumor therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-tumor therapy, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogues, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter prior to first dose of study treatment.\n4. Toxicities of prior therapy have not resolved to Grade ≤1 or to baseline (as evaluated by NCI CTCAE version 5.0)\n5. History of another primary tumor that has been diagnosed or required therapy within the past 3 years.\n6. Previous history of, or presence of Gilbert's syndrome.\n7. Previous history of myelodysplastic syndrome.\n8. Prior solid organ or hematopoietic stem cell transplant.\n9. Known active central nervous system (CNS) primary tumor or untreated CNS metastases.\n10. Have serious cardiovascular or cerebrovascular disease as per protocol.\n11. Presence of uncontrolled systemic infection as per protocol.\n12. Unwillingness or unable to comply with the requirements of oral drug administration, or presence of a gastro-intestinal condition.\n\nOther protocol inclusion and exclusion criteria may apply.","ALL","18 Years",{"count":19,"type":20},114,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The study has consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2). The primary objectives of this study are to evaluate the safety and tolerability of ISM3412 in participants with locally advanced\u002Fmetastatic solid tumors, and to determine the RP2D of ISM3412.",[27],"Locally Advanced\u002FMetastatic Solid Tumors",[29,30,31,32],"Methionine adenosyltransferase 2A (MAT2A)","homozygous MTAP deletion","MAT2A inhibitor","ISM3412","RECRUITING","2026-06-16",{"date":36,"type":37},"2026-06-18","ACTUAL",{"date":39,"type":37},"2025-04-25",{"date":41,"type":20},"2029-03-31",{"name":43,"class":44},"InSilico Medicine Hong Kong Limited","INDUSTRY",10,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":5},"100591380","phase-1-study-of-esg406-in-adults-with-solid-tumors-100591380","NCT06979674","Study of ESG406 in Adults With Solid Tumors","An Open-Label, Multiple Dose, Dose Escalation and Cohort Expansion Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of ESG406 in Subjects With Locally Advanced\u002FMetastatic Solid Tumors","Key Inclusion Criteria:\n\n* Males and females aged 18 to 80 years.\n* Histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable.\n* At least one measurable lesion per RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥12 weeks.\n* Adequate organ and bone marrow function.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after last investigational product administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause.\n\nKey Exclusion Criteria:\n\n* Use of any cancer therapy (chemotherapy or other systemic anti-cancer therapies, immunotherapy) within 4 weeks before the first investigational product administration.\n* Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1.\n* Had major surgery within 4 weeks before dosing, or will not have fully recovered from surgery; or has surgery planned during the time the subject is expected to participate in the study or within 4 weeks after the last dose of study drug administration.\n* Use of any investigational anti-cancer drug within 4 weeks or 5 half-lives before the first investigational product administration.\n* A history of thromboembolic or cerebrovascular events within 6 months prior to the first dose of the investigational drug.\n* History of (noninfectious) interstitial pneumonia (ILD)\u002Fnoninfectious pneumonitis requiring steroid therapy and current ILD\u002Fnoninfectious pneumonitis, or suspected ILD\u002Fnoninfectious pneumonitis at screening.\n* Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases.\n* Patients with Primary CNS malignancy, or patients with other malignancies within 3 years prior to the first dose.\n* Patients with uncontrollable systemic diseases.\n* Subjects with clinically significant cardiovascular disease.\n* Human Immunodeficiency Virus (HIV) infection.\n* Active hepatitis B or hepatitis C.\n* Have an allergic constitution, or to be allergic to any investigational drug or excipient ingredient.\n* Pregnant or lactating women.","80 Years",{"count":55,"type":20},556,[23],"This study is an open-label, dose-escalation and cohort expansion Phase I study, aiming to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of ESG406, and determine the MTD, RP2D and administration regimens of ESG406. The study includes the dose escalation study in Phase Ia and the cohort expansion study in Phase Ib.",[27],"2025-09-08",{"date":61,"type":37},"2025-09-12",{"date":63,"type":37},"2025-06-04",{"date":65,"type":20},"2028-06",{"name":67,"class":44},"Shanghai Escugen Biotechnology Co., Ltd",{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100500821","phase-1-pe0116-and-pe0105-injection-in-treatment-of-patients-with-advanced-solid-tumor-100500821","NCT05801237","PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor","A Phase Ib\u002FII Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n1. Patients who voluntarily sign the informed consent form, understand the study and are willing to follow and able to complete all study procedures;\n2. Male or female, 75 ≥ age ≥ 18 years;\n3. Patients who have histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors that are refractory to or intolerable with standard treatment, or for which no standard effective treatment is available;\n4. Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;\n5. Patients who have a life expectancy of at least 3 months;\n6. Patients who have at least one evaluable lesion in Phase Ia study, and have measurable lesions in Phase Ib (according to RECIST v1.1). Tumor lesions in the area of prior radiotherapy (or other local therapy) with unequivocal progression after radiotherapy as confirmed by imaging can be considered as measurable lesions;\n7. Patients who are ≥ 4 weeks after receiving anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, endocrine therapy and immunotherapy, before the first dose of study drug, with the following exceptions:\n\n   1. ≥ 6 weeks after receiving nitrosourea or mitomycin C before the first dose of study drug;\n   2. ≥ 2 weeks or 5 half-life periods (whichever is longer) of oral fluorouracils and small molecule targeted agents before the first dose of study drug;\n   3. ≥ 2 weeks after receiving traditional Chinese medicine with anti-tumor indications before the first dose of study drug；\n8. Patients who have suitable organ and hematopoietic function without severe heart, lung, liver, renal dysfunction and immunodeficiency according to the following laboratory tests:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL;\n   2. Absolute white blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL;\n   3. Platelets ≥ 75 x 10\\^9\u002FL;\n   4. Hemoglobin ≥ 90 g\u002FL;\n   5. Serum creatinine ≤ 1.5 times the upper limit of normal (ULN);\n   6. AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver cancer or metastases to liver;\n   7. Serum total bilirubin (TBIL) ≤ 1.5 × ULN;\n   8. International normalized ratio (INR) ≤ 1.5 × ULN and activated partial thromboplastin time (APPT) ≤ 1.5 × ULN (except for patients receiving anticoagulant therapy);\n   9. Myocardial enzyme CK and CKMB test values are within the normal range, or mildly abnormal but judged by the investigator to be suitable for enrollment;\n   10. Thyroid function (FT3, FT4, and TSH) test values are within the normal range, or mildly abnormal but judged by the investigator to be suitable for enrollment.\n9. Male subjects and female subjects of childbearing potential should agree to use effective contraception from the signing of the informed consent form until 3 months after the last dose.\n\nExclusion Criteria:\n\n1. Subjects who have central nervous system metastasis with clinical symptoms (e.g., brain edema, hormone intervention required, or progression of brain metastasis) and\u002For carcinomatous meningitis. However, subjects who have received prior treatment for brain or meningeal metastases can be included if they have remained stable clinically for at least 2 months and systemic hormone therapy (prednisone at a dose of \\> 10 mg\u002Fday or other hormone at an equivalent dose) has been discontinued for more than 4 weeks;\n2. Subjects who fail to recover from adverse reactions of prior therapies to ≤ CTCAE V5.0 Grade 1. (Patients with residual alopecia, chromatosis and peripheral neurotoxicity that has recovered to ≤ CTCAE Grade 2, and with long-term toxicity caused by radiotherapy that cannot recover as judged by the investigator may be included);\n3. Subjects with systemic diseases that have not been stably controlled after treatment, such as history of severe cardiovascular and cerebrovascular diseases, diabetes mellitus, hypertension, etc.;\n4. Subjects who have any active auto-immune disease or evidence of auto-immune disease, or systemic syndrome previously requiring treatment with systemic steroids or immunosuppressive drugs. (Patients with inactive vitiligo, psoriasis and post-treatment childhood asthma\u002Fatopy within 2 years, or thyroid disease that has been controlled with alternative therapy\u002Fnon-immunosuppression may be included);\n5. For subjects requiring systemic treatment with corticosteroids (at doses equivalent to \\> 10 mg prednisone\u002Fday) or other immunosuppressive agents within 14 days prior to enrollment or during the study period, enrollment is allowed under the following situations:\n\n   1. Subjects are allowed to use topical or inhaled glucocorticoids;\n   2. Short-term (≤ 7 days) use of glucocorticoids for the prophylaxis or treatment of non-autoimmune allergic diseases is permitted;\n6. Subjects who have a history of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation, or a history of stem cell transplantation;\n7. Patients with tuberculosis that is active at screening;\n8. Patients with active chronic hepatitis B or active hepatitis C. Patients as hepatitis B virus carriers, and with stable hepatitis B after drug treatment (DNA titers should not be higher than 1000 copies\u002FmL), and cured hepatitis C (HCV RNA test results are required to be below the lower limit of the testing site) can be enrolled;\n9. Patients who have received treatment with anti-4-1BB targeting drugs;\n10. Patients with a known history of severe allergic reactions (CTCAE v5.0 ≥ Grade 3) to macromolecular protein preparations\u002Fmonoclonal antibodies, or to any component of the study drug;\n11. Patients who are expected to have major surgery during the study, including the 28-day screening period;\n12. Patients with serious infection within 4 weeks prior to the first dose, or with active infection requiring oral or intravenous antibiotics within the first 2 weeks;\n13. Patients who have participated in clinical trial of another drug within 4 weeks prior to enrollment and enrolled for drug treatment, or are less than 4 weeks after end of treatment (EOT);\n14. Patients who have a history of alcohol abuse, drug addiction or drug abuse in the past 1 year;\n15. Present with ≥ grade 3 irAE or ≥ grade 2 immune-associated myocarditis during previous immunotherapy;\n16. Previous or current history of other primary malignant tumors; Except basal cell carcinoma of skin, superficial bladder carcinoma, squamous cell carcinoma of skin or cervical carcinoma in situ; Or those who have received radical treatment and have not relapsed within 5 years of treatment;\n17. A history of moderate or severe dyspnea at rest due to advanced malignancy or its complications or severe primary lung disease, or a current need for continuous oxygen therapy, or a current ILD or pneumonia;\n18. Patients who used live attenuated vaccine within 4 weeks prior to the first dose or plan to use such vaccine during the course of the study;\n19. Patients with a previous history of definite neurological or mental disorders, including epilepsy, dementia and poor compliance;\n20. Pregnant or breastfeeding women; eligible patients (males and females) of childbearing potential who do not agree to use a reliable method of contraception (hormonal or barrier method, or abstinence) during the trial and for at least 3 months after the last dose; and female patients of childbearing potential who have a positive blood or urine pregnancy test within 7 days prior to enrollment.\n21. Subjects who, in the opinion of the investigator, are not suitable for the study for other reasons.","75 Years",{"count":77,"type":20},120,[23,24],"This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients with Advanced Solid Tumor.",[27],"2023-12-11",{"date":83,"type":37},"2023-12-15",{"date":85,"type":37},"2023-09-21",{"date":87,"type":20},"2026-12",{"name":89,"class":44},"Shanghai HyaMab Biotech Co.,Ltd.",1]